Jin Wen-Shu, Yin Lu-Xu, Sun Hua-Qiang, Zhao Zhang, Yan Xin-Feng
Department of Hospital-Acquired Infection Control, The Second Affiliated Hospital of Shandong First Medical University, Taian City, Shandong Province, China.
Department of Orthopedic Surgery, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, Shandong Key Laboratory of Rheumatic Disease and Translational Medicine, Jinan City, Shandong Province, China.
Arthroscopy. 2025 Feb;41(2):318-332. doi: 10.1016/j.arthro.2024.07.027. Epub 2024 Aug 16.
To evaluate the efficacy and safety of intra-articular injection of mesenchymal stem cells (MSCs) versus hyaluronic acid (HA) in the treatment of knee osteoarthritis (KOA).
Eligible randomized controlled trials (RCTs) were identified through a search of PubMed, Embase, the Cochrane Library, Web of Science, SinoMed, and CNKI databases from inception to March 2024. For meta-analysis, data on clinical outcomes were measured using visual analog scale (VAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and data on cartilage repair were measured using the Whole-Organ Magnetic Resonance Imaging Score (WORMS); data on safety were evaluated by the incidence of adverse events. Two researchers independently read the included literature, extracted data and evaluated the quality, used the Cochrane risk bias assessment tool for bias risk assessment, and used RevMan5.3 software for meta-analysis.
Ten RCTs involving 818 patients with KOA ranging from I to Ⅲ on the Kellgren-Lawrence grading scale were included in this meta-analysis. Meta-analysis results showed that at 12 months, the WOMAC total score (mean difference [MD] = -10.22, 95% confidence interval [CI]: -14.86 to -5.59, P < .0001, Z = 4.32), VAS score (MD = -1.31, 95% CI: -1.90 to -0.73, P < .0001, Z = 4.40); and WORMS score (MD = -26.01, 95% CI: -31.88 to -20.14, P < .001, Z = 8.69) of the MSCs group all decreased significantly (P < .05) compared with the HA control group and reached the minimal clinically important differences. Furthermore, there was no significant difference in the incidence of adverse events (relative risk = 1.54, 95% CI: 0.85-2.79, P = .16, I = 0) between the 2 groups (P > .05).
In terms of efficacy, the clinical effects of intra-articular injection therapy using MSCs for KOA are superior to those of HA, and the cartilage repair effect of MSCs is also markedly better than that of HA. Although the clinical effects varied across time periods, the functional score reached the minimum clinically significant difference at both 6 and 12 months. In terms of safety, adverse reactions mainly manifest as joint pain, swelling, and joint effusion. Both intra-articular injections of MSCs and HA did not result in severe adverse reactions, indicating that MSCs and HA have similar safety profiles.
Level I, meta-analysis of Level I studies.
评估关节腔内注射间充质干细胞（MSCs）与透明质酸（HA）治疗膝关节骨关节炎（KOA）的疗效和安全性。
通过检索PubMed、Embase、Cochrane图书馆、Web of Science、中国生物医学文献数据库和中国知网数据库，从建库至2024年3月，识别符合条件的随机对照试验（RCT）。对于荟萃分析，使用视觉模拟量表（VAS）和西安大略和麦克马斯特大学骨关节炎指数（WOMAC）测量临床结局数据，使用全器官磁共振成像评分（WORMS）测量软骨修复数据；通过不良事件发生率评估安全性数据。两名研究人员独立阅读纳入文献，提取数据并评估质量，使用Cochrane偏倚风险评估工具进行偏倚风险评估，并使用RevMan5.3软件进行荟萃分析。
本荟萃分析纳入了10项RCT，涉及818例Kellgren-Lawrence分级为I至Ⅲ级的KOA患者。荟萃分析结果显示，在12个月时，MSCs组的WOMAC总分（平均差[MD]= -10.22，95%置信区间[CI]：-14.86至-5.59，P <.0001，Z = 4.32）、VAS评分（MD = -1.31，95%CI：-1.90至-0.73，P <.0001，Z = 4.40）和WORMS评分（MD = -26.01，95%CI：-31.88至-20.14，P <.001，Z = 8.69）与HA对照组相比均显著降低（P <.05），并达到最小临床重要差异。此外，两组之间不良事件发生率无显著差异（相对风险= 1.54，95%CI：0.85 - 2.79，P =.16，I² = 0）（P >.05）。
在疗效方面，关节腔内注射MSCs治疗KOA的临床效果优于HA，且MSCs的软骨修复效果也明显优于HA。尽管临床效果随时间段有所不同，但在6个月和12个月时功能评分均达到最小临床显著差异。在安全性方面，不良反应主要表现为关节疼痛、肿胀和关节积液。关节腔内注射MSCs和HA均未导致严重不良反应，表明MSCs和HA具有相似的安全性。
I级，I级研究的荟萃分析。
